1. Field of the Invention
This invention relates to protective sleeves and, more particularly, to a novel protective sheath apparatus and method for protecting surgical conduits from gross contamination during a surgical procedure, the protective sheath also providing a securement mechanism for securing the surgical conduits to the sterile field during the surgical procedure.
2. The Prior Art
The emerging field of arthroscopy and laparoscopy as accepted surgical procedures has enjoyed an explosive growth within the past few years. This explosive growth has been made possible in large part by the advances in both the optical systems used for enabling the surgeon to visually observe the particular surgical site along with vastly improved tools for accomplishing the particular surgical procedure. These optical systems include optical fiber bundles which serve the dual purposes of introducing light into the surgical site to enable the surgeon to both observe and video record what is being seen. The surgical instruments include power driven cutters, suction lines, saline lines, fiber optic bundles for lasers, and the like.
The primary advantage afforded by these surgical procedures is that the wound site is quite small thereby requiring less anesthetic and a shorter hospital stay with a consequent more rapid recovery by the patient. Indeed, many procedures which once required extensive hospitalization are now performed routinely on an outpatient basis using these recent innovations. However, as the instrumentation becomes smaller it has also created other problems particularly for the medical professionals who provide support services to the surgeon both during and after the surgical procedure.
For example, one particularly vexing problem is that of maintaining the sterility of the various conduits used during the surgical procedure. In particular, three, four, or more conduits will enter the sterile field from the various pieces of support equipment placed around the periphery of the surgical suite. These conduits tend to slip off the operating table and become nonsterile which is an absolutely unacceptable consequence.
Perhaps an even greater problem is that of gross contamination of the conduits during the surgical procedure. This contamination is caused by the accumulation of body fluids, tissue, fats, etc. from the patient and must be removed before the particular conduit can be subjected to cold sterilization prior to reuse. Experience has shown that these items of equipment are subjected to harsh treatment through vigorous scrubbing by the medical professionals responsible for their cleanup after a surgical procedure. One result of such harsh physical treatment is the destruction of optical fibers in a fiber optical bundle along with destruction of the protective covering of a conduit, to name a few. One hospital in particular has found it necessary to have several extra sets of surgical conduits on hand at all times in order to have sufficient support capability to compensate for the times when various pieces of this equipment are returned to the manufacturer for refurbishing. Not only is this an added expense but one must also take into account the extra time required for a medical professional to scrub the various conduits. This extra handling is an added cost in that the time expended by the medical professional is costly. Also, any residual contamination results in a reduction in the effective life of the cold sterilization solution which is an added expense.
Various types of protective devices are known and included, for example, a protective device for a hypodermic needle as taught by Rosenberg (U.S. Pat. No. 4,857,060. This protective device has an annular, radially projecting membrane that is mounted to the hub of the hypodermic needle in a shirt-like fashion so that the membrane can be splayed radially to shield the operator from body fluids while performing an injection with the hypodermic needle. The hem portion of the shirt-like membrane includes a drawstring to close the membrane about the needle after withdrawal of the needle from the patient. Closure of the shirt-like membrane creates a box-like enclosure about the hypodermic needle.
Another protective device is that of Anapliotis (U.S. Pat. No. 5,239,981). Anapliotis teaches a film covering to protect a surgical instrument such as an endoscope. A circular membrane 5 has an aperture 7 therein through which the distal end of a surgical instrument is inserted into the tubular film covering 1. The film covering 1 is folded in a telescopic manner prior to extension over the surgical instrument. The circular membrane 5 is fabricated from an elastic material to accommodate the aperture 7 being stretched over various sizes, connectors, and the like, of the surgical instrument.
Hampson (U.S. Pat. No. 4,327,735) discloses a catheter assembly having a transparent, collapsible sleeve, the collapsible sleeve being sealed at one end to a hollow tube and terminating at its other end in an O-ring.
Muto (U.S. Pat. No. 4,392,853) discloses a tubular sheath of transparent, relatively limp, impervious plastic for protecting and affixing an indwelling catheter.
Cassou (U.S. Pat. No. 4,453,936) discloses a protective sleeve for a gynecological gun used in the artificial insemination of animals.
Dastgeer (U.S. Pat. No. 4,596,554) discloses a colo-rectal evacuator used for mechanically removing waste material through a patient's rectum. The evacuator is enclosed in a disposable bag into which the wastes are collected for subsequent disposal.
Palmer (U.S. Pat. No. 4,836,199) discloses an aspirating catheter tube internally disposed within and coextensive with a surrounding flexible and collapsible, sterility-preserving film envelope.
Seitz, Jr. (U.S. Pat. No. 4,877,033) discloses a sterile plastic sheath for covering a transvaginal ultrasound probe during nonoperative diagnostic examinations. A second, durable plastic sheath is fitted over the transvaginal ultrasound probe to protect it from accidental damage during storage.
Anapliotis (U.S. Pat. No. 5,061,246) discloses a tube-like covering for protecting an elongated surgical instrument. The covering is initially in a telescopically folded configuration prior to receipt therein of the surgical instrument.
Adair (U.S. Pat. No. Re. 33,854) discloses a rigid heat sterilizable outer sheath for a video endoscope. The video endoscope releasably locks into the outer sheath. The outer sheath also includes an accordion-shaped sleeve at the proximate end which can be drawn around the trailing cables of the video endoscope so that the entire endoscope is sterile for use within the operating room.
Woodgrift et al. (U.S. Pat. No. 5,149,326) discloses an adjustable catheter contamination shield having a distal fitting, a proximal fitting, and a collapsible shield disposed between the distal fitting and the proximal fitting.
Kurtzer (U.S. Pat. No. 5,168,863) discloses a covering for an endoscopic device, the covering including a pair of generally orthoganally arranged component bags to enclose the respective elements of the endoscopic device.
Erlich (U.S. Pat. No. 5,181,913) discloses a tubular sheath for a catheter for use in removing body fluids. The tubular sheath is disposed in a rolled-up fashion around the catheter to aid in the sterile disposal of the catheter.
Burton (U.S. Pat. No. 5,228,851) discloses a single-use, disposable prophylactic elastic sleeve for placement on a handle of a dental or medical instrument. Finger engaging, ring-shaped retention members on each end of the sleeve aid in placing and expanding the elastic sleeve from a collapsed position into placement over the instrument.
In view of the foregoing, it would be an advancement in the art to provide a protective sheath for encasing a plurality of surgical conduits. Another advancement in the art would be to provide a protective sheath that will not only help prevent the surgical conduits from falling off the operating table but also shield them from a substantial portion of the contamination that would otherwise be found thereon. An even further advancement in the art would be to provide a disposable sheath that can be provided in a sterile condition and easily mounted upon and removed from the surgical conduits. Such a novel apparatus and method is disclosed and claimed herein.